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A Study to Determine the Prevalence of Inflammatory Dry Eye Disease in Patients Prior to Cataract Removal (REVEAL)

2. November 2015 aktualisiert von: Allergan
This study will evaluate the prevalence of inflammatory dry eye disease in patients prior to cataract surgery. No treatment is administered in this study.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

204

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Kanada
    • Manitoba
      • Brandon, Manitoba, Kanada
    • Nova Scotia
      • Halifax, Nova Scotia, Kanada
    • Ontario
      • Barrie, Ontario, Kanada
      • Ottawa, Ontario, Kanada
      • Toronto, Ontario, Kanada
    • Quebec
      • Boisbriand, Quebec, Kanada

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

50 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Patients with planned cataract removal surgery

Beschreibung

Inclusion Criteria:

  • Scheduled to undergo cataract removal surgery

Exclusion Criteria:

  • Current use of eye drops or oral medications for allergic conjunctivitis
  • Serious ocular injury, intraocular surgery, or refractive surgery within 6 months in the study eye
  • Use of a contact lens within 4 weeks

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
Patients with Planned Cataract Removal
Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
Sonstiges: Kein Eingriff
Kein Eingriff

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Patients With a Presence of Matrix Metalloproteinase-9 (MMP-9) in the Study Eye
Zeitfenster: Up to 60 Days Prior to Surgery
Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye.
Up to 60 Days Prior to Surgery

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants Suspected of Having Dry Eye With Elevated MMP-9
Zeitfenster: Up to 60 days prior to cataract surgery
Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Suspected of having dry eye was defined as a response of "Yes" to the Investigator Dry Eye History question.
Up to 60 days prior to cataract surgery
Percentage of Participants With Elevated MMP-9 Without Prior Diagnosis or Physician Recommended Intervention
Zeitfenster: Up to 60 days prior to cataract surgery
Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Participants without a prior diagnosis of keratoconjunctivitis sicca, dry eye or tear film insufficiency or physician recommended use of topical cyclosporine, artificial tears or punctal plugs are included in the analysis.
Up to 60 days prior to cataract surgery
Percentage of Participants With Elevated MMP-9 With Dry Eye Symptoms Without Conjunctival or Corneal Staining
Zeitfenster: Up to 60 days prior to cataract surgery
Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Dry eye symptoms were measured by a score of at least ≥ 2 using the Subject Evaluation of Symptoms of Dryness (SESoD) questionnaire without conjunctival or corneal staining. The SESoD assesses dry eye using a 5-point scale where 0= no dryness to 4= severe dryness. Conjunctival and Corneal Staining were evaluated as part of the slit lamp biomicroscopy examination. Eye structures and surfaces were assessed for dry eye signs using a 5-point scale where: 0=none, 0.5=trace, 1=mild, 2=moderate and 3=severe. Higher values represent a worse outcome.
Up to 60 days prior to cataract surgery
Percentage of Participants With Elevated MMP-9 With Dry Eye Symptoms Without Any Signs
Zeitfenster: Up to 60 days prior to cataract surgery
Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Dry eye symptoms were measured by a score of at least ≥ 2 using the SESoD questionnaire without any signs. The SESoD assesses dry eye using a 5-point scale where 0= no dryness to 4= severe dryness. Signs included conjunctival or corneal staining, Schirmer's score ≤ 7mm, or Tear Film Break-up Time [TFBUT] ≤ 10 seconds.
Up to 60 days prior to cataract surgery
Percentage of Participants With Elevated MMP-9 With at Least One Dry Eye Sign Without Dry Eye Symptoms
Zeitfenster: Up to 60 days prior to cataract surgery
Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Dry Eye Signs included conjunctival or corneal staining, Schirmer's score ≤ 7 mm, or Tear Film Break-up Time [TFBUT] ≤ 10 seconds without Dry eye symptoms measured by a score of at least ≤ 1 using the SESoD questionnaire. The SESoD assessed dry eye using a 5-point scale where 0= no dryness to 4= severe dryness.
Up to 60 days prior to cataract surgery
Percentage of Participants With Elevated MMP-9 With at Least One Dry Eye Sign and Dry Eye Symptoms
Zeitfenster: Up to 60 days prior to cataract surgery
Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Dry Eye Signs included conjunctival or corneal staining, Schirmer's score ≤ 7mm, or Tear Film Break-up Time [TFBUT] ≤ 10 seconds with Dry eye symptoms measured by a score of at least ≥ 2 using the SESoD questionnaire. The SESoD assessed dry eye using a 5-point scale where 0= no dryness to 4= severe dryness.
Up to 60 days prior to cataract surgery
Percentage of Participants With Elevated MMP-9 Who Routinely Use Artificial Tears
Zeitfenster: Up to 60 Days Prior to Surgery
Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Artificial Tear usage was assessed by the investigator.
Up to 60 Days Prior to Surgery
Percentage of Participants With Elevated MMP-9 With Punctal Plugs
Zeitfenster: Up to 60 Days Prior to Surgery
Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. A history of punctual plug usage was assessed by the investigator.
Up to 60 Days Prior to Surgery
Percentage of Participants With Elevated MMP-9 With Corneal Staining Grade ≥ 1 and ≥ 2
Zeitfenster: Up to 60 Days Prior to Surgery
Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. Corneal Staining was evaluated as part of the slit lamp biomicroscopy examination. Eye structures and surfaces were assessed for signs of dry eye using a 5-point scale where: 0=none, 0.5=trace, 1=mild, 2=moderate and 3=severe. Higher values represent a worse outcome.
Up to 60 Days Prior to Surgery
Percentage of Participants With Elevated MMP-9 and an Ocular Surface Disease Index® (OSDI®) > 12, > 22 and ≥ 32
Zeitfenster: Up to 60 Days Prior to Surgery
Tear film was collected and a diagnostic test was used to determine the presence of MMP-9 in the study eye. The OSDI consists of 12 questions to assess visual function, ocular symptoms and environmental triggers related to dry eye. Each of the 12 questions is assessed using a 5-point scale (0=none of the time to 4=all of the time) which is converted to a total score between 0-100. OSDI total scores of 0-12=normal (best), 13-22= mild ocular surface disease, 23-32 =moderate ocular surface disease, and 33-100=severe ocular surface disease (worst).
Up to 60 Days Prior to Surgery

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Allergan

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Juni 2013

Primärer Abschluss (Tatsächlich)

1. März 2014

Studienabschluss (Tatsächlich)

1. März 2014

Studienanmeldedaten

Zuerst eingereicht

18. Juni 2013

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

18. Juni 2013

Zuerst gepostet (Schätzen)

20. Juni 2013

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

3. Dezember 2015

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

2. November 2015

Zuletzt verifiziert

1. November 2015

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • GMA-RES-012-001

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